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Assay and Purity Evaluation of Sunepitron Hydrochloride by Reversed-Phase Liquid Chromatography Using a Reference Standard Composite

Assay and Purity Evaluation of Sunepitron Hydrochloride by Reversed-Phase Liquid Chromatography Using a Reference Standard Composite

S T Colgan, M L Dumont, S G Ruggeri

J Pharm Biomed Anal. 1998 Nov;18(3):429-40.

PMID: 10096837

Abstract:

A reference standard composite was prepared that contained the active pharmaceutical ingredient sunepitron and three potential impurities. This standard was characterized and used for concomitant quantitation of sunepitron and its potential impurities in samples of drug substance and drug product. This approach minimizes the number and quantity of reference standards which often are expensive to synthesize, characterize, and maintain. In addition, running assays becomes simpler because the number of reference standard solutions required for each assay is reduced. Reference standard composites can also be used for qualitative applications such as demonstrating system suitability or for retention times markers for process related impurities or degradants.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP148408655	Sunepitron hydrochloride		148408-65-5	Price

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